The medical device industry
today has numerous standards
and regulations to follow,
most notable amongst them being ISO 9001 and ISO 13485. However, these requirements have a shared blind spot: critical processes (heat treating, sterilization, etc.). In the medical industry, all of the standards and audits suppliers need to adhere to focus on general system quality. If the critical processes aren’t
being looked at equipment can still fail because of poor craftsmanship.